Heavily regulated and process oriented industries such as: oil & gas, food (e.g., agriculture products, processed food, meat/poultry etc.), beverages (e.g., consumable liquids such as spirits, wine, beer, juice, etc.), chemicals, consumer products (e.g., cosmetics and skin care), and pharmaceutical drugs {e.g., chemical and bioprocess development, also known as drug substance and pharmaceutical development, also known as drug product, as well as generics), share a number of common characteristics. These kinds of heavily regulated process industries are extensively regulated by local, state, federal and international agencies (e.g., Food and Drug Administration (FDA), Trade and Tax Bureau (TTB part of Treasury)) to ensure that safe and efficacious products are consumed by the public and that each of the products presented by companies in these aforementioned industries are not fraudulent or harmful (e.g., that the product integrity is maintained for the life of the product). The product integrity is proven by comparing product records at one point in time against product history records of another point in time during the development, manufacturing and commercial sale of these products. Key elements of product history information include specifications, attributes, processes, equipment, material, people involved, standards followed or established, as well as physical conditions under which products were produced. This is challenging for these kinds of heavily regulated process industries because, by nature, they tend to produce products that are dynamically changing or very complex. Thus, the information associated with these product history records becomes more difficult to manage over the lifecycle of development. For example, these industries may require highly variable raw materials such as proteins secreted from mammalian cells or grape juice extracted from agriculture vine-grapes. These raw materials are then transformed into intermediate materials and then finally into final products delivered in a safe and efficacious form ingestible by humans. Companies might also be required to preserve this product history, for example, for submission to regulatory agencies to gain approval to commercially manufacture these products. Furthermore, as companies develop new products, they may begin with the “end in mind”, turning to these past product histories as “prior knowledge” and relying on their justifications and rationale to regulatory authorities on this multi-variate-dimensional “model” to prove quality is built into the process, or that they followed a “Quality by Design (QbD) approach”.
Another major requirement for “heavily regulated industries” is the ability of a company to demonstrate that it's production processes from development through commercial manufacturing are fully traceable, meaning that a third party (such as an Agency, e.g., FDA) could come in and demand to see product history from one point in time to another. A single source of truth exists for each product history. For instance, a company must be able to prove that “what it is producing is indeed being produced, in the manner it claims to be being produced in.” These onsite inspections, audits, and information requests often focus on a particular process for a particular set of materials from one point in time to another. Failure to provide immutable proof of product history traceability has subjected companies to hefty fines as well as shutdowns.
In addition for failure to provide proof of the process over time, these industries are usually subject to large fines-or delays in production/shutdowns for non-compliance of any part of the submission application, audits, labels, waste, emissions, safety, etc. Payment of appropriate taxes is an ongoing challenge as the payments are determined by the “amount produced” and “type” of product produced, all of which require extensive record keeping along many dimensions over time.
These industries are also “heavily process oriented” meaning that products are produced in a manner that consists of extensive combinations of steps such as complex blends, formulations and recipes. Another drawback is that in some of these industries (e.g., the pharmaceutical and beverage industries) extensive record keeping is required to create the product history “paper trail.” Typically, the kind of record keeping required by these industries is a complete history of the product's lifecycle, often spanning from the raw materials to the final product and inclusive of all intermediate products across the supply chain. The type of information required in the record keeping of product history typically spans the following dimensions: personnel and their training requirements, process, materials, equipment, standards, and facility/environment information which collectively form the comprehensive information for the specified record.
These industries may also have complex order tracking for work personnel, equipment materials, processes (e.g., campaign planning and execution, work order generation, etc.). For instance, tracking the state of materials from raw material to intermediates, to final products etc. or tracking the equipment history (calibration, cleaning, usage, etc.) requires a number of different kinds/pieces of information making it a complex process. Not only does the information in these areas have to be recorded and tracked, but it must be compared to standards set both internally within a company and externally by regulating authorities. Furthermore, it must be compared to itself at differing points in time (e.g., Commercial Manufacturing takes place in Year 9 and the equipment set up, calibration, cleaning, usage must be recorded, tracked and compared against the equipment history in Year 8, which was submitted to the FDA and is what the company's license to commercially manufacture is based upon.).
These types of regulated process industries are further challenged in that a number of different indirect/input goods are produced along the path of creating the final product and all of these indirect/input/intermediate goods have be managed in a similar manner of recording information/tracking/comparing to different points in time as described above. Visibility is essential to achieving this comprehensive record keeping and management of information in these regulated process industries, yet at present these industries have low visibility at all levels of process input and product history across the supply chain.
Currently there are no broad web-based solutions that fully meet these kinds of complex quality and product integrity needs such as comprehensive product history record keeping in process management of heavily regulated industries. In fact, many of the record keeping functions and filing processes for federal and state regulations still occur through outdated manual time-consuming means.